BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPOLE

    MDR report key: 2821121 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-12383
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED LOSS OF PAIN COVERAGE IN RIGHT FOOT, WHILE COVERAGE TO OTHER AREAS ARE ADEQUATE. X-RAYS CONFIRMED THE LEAD IS LEFT OF MIDLINE. FOLLOW UP DETERMINED THE PHYSICIAN PLANS SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPOLE SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3219 3706154

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788